new ovplex publication and new prospective tri

HealthLinx Limited
ABN 88 098 640 352
576 Swan Street Richmond VIC 3121
Telephone: +61 3 9208 4200 I Facsimile: +61 3 9208 4201
www.healthlinx.com.au
New OvPlex™ Publication and
Announcement of New Prospective Trial
29 March 2012, Melbourne: HealthLinx Limited (ASX:HTX) is pleased to announce that
interim data from its ongoing multinational trial of the OvPlex™ test has been published
in the peer-reviewed Journal of Translational Medicine (http://www.translationalmedicine.
com/content/10/1/45/abstract). This study confirms in an independent sample
set that the OvPlex™ assay has significant clinical advantages over CA125 for
distinguishing symptomatic women with borderline and malignant ovarian cancer from
controls or those with benign disease. A synopsis of these data was previously released to
the market in an announcement on 16 December, 2011.
As the present trial enters its final stages, the highly significant interim result has
prompted Healthlinx to establish a follow-up pivotal trial which will determine the
efficacy of the OvPlex™ test in a true prospective setting. HealthLinx has extended its
current collaboration with Queensland’s Mater Health Services with Associate Professor
Lewis Perrin to oversee the design and implementation of the prospective trial that will
source patients from Mater Health Services clinics. This study will be a 12 month study
where the first 9 months will be used to recruit patients and the remaining 3 months for
data analysis.
“This type of trial represents a pivotal test of the efficacy of the OvPlex™ diagnostic test
in a clinical setting” said managing director Mr Nick Gatsios. “Further clinical validation
will only build on evidence, increasing support for market acceptance, and ultimately
sales of OvPlex™” Mr Gatsios added.
On behalf of the Mater Gynaecological Oncology department, Associate Professor Lewis
Perrin stated, “The diagnosis of a pelvic mass can cause severe anxiety for any patient
and her family. This test has the potential to identify patients who would be best
managed by a gynaecological oncologist. We hope with further validation that we could
begin to incorporate this test into clinical practice in the next year. In a tertiary centre
like the Mater Brisbane, that provides a state-wide service, appropriate triage of patients
is important to prevent unnecessary anxiety, travel and costs to the patient and the
health service.”
The collaboration will also extend further with an expansion of the immunohistochemistry
study (the initial positive results were announced on 15 February 2012) to
obtain unequivocal clinical data on the novel biomarker that presents as a prognostic
biomarker for patient survival. The company has recently filed for a provisional patent to
cover this novel invention. The study will seek to answer a number of additional clinical
questions that will further enhance the potential clinical utility of the said biomarker.